Long-term Outcomes Data Shared at SSO 2024 Show That Patients with a Low-Risk DecisionDx®-Melanoma Test Result Were Recurrence Free at Three Years, Including Those Who Utilized the Test to Help Guide the Decision to Avoid an SLNB
22 Marzo 2024 - 2:30PM
Business Wire
Castle’s second presentation at SSO 2024 shows
that in a study of 979 patients, DecisionDx-Melanoma demonstrated
clinical use value in patients with TI cutaneous melanoma (CM),
identifying high-risk patients who could consider a more intensive
treatment pathway, such as a sentinel lymph node biopsy (SLNB) and
imaging surveillance
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced that new data highlighting the performance of its
DecisionDx-Melanoma test in predicting risk of sentinel lymph node
(SLN) positivity in patients with CM is being presented at the
Society of Surgical Oncology 2024 (SSO 2024) Annual Meeting, being
held March 20-23 in Atlanta.
“We have previously demonstrated that our DecisionDx-Melanoma
test identifies patients who are eligible for an SLNB but have less
than a 5% likelihood of being SLN positive, and could therefore
consider avoiding the procedure,” said Derek Maetzold, president
and chief executive officer of Castle Biosciences. “We have also
demonstrated that our test is a strong and independent predictor of
metastasis. The study that was orally presented at SSO 2024
demonstrates that patients who did avoid an SLNB procedure had
excellent outcomes to date. This demonstration is highly important
as it showed that our test can help patients avoid an unnecessary
procedure.”
DecisionDx-Melanoma is supported by 50 peer-reviewed
publications involving more than 10,000 patient samples,
demonstrating its robust value in guiding risk-aligned patient
care. The test has been designed and validated to inform two
clinical questions in the management of melanoma: a patient’s risk
of melanoma recurrence and metastasis, and their individual risk of
SLN positivity, as highlighted in Castle’s SSO 2024 abstracts
outlined below.
DecisionDx®-Melanoma
- Oral Presentation Number and Title: 62: Prospective
validation of the i31-gene expression profile test for cutaneous
melanoma to select patients who may consider foregoing sentinel
lymph node biopsy
- Session: Melanoma Parallel Session
- Presenter and Lead Author: J. Michael Guenther, M.D.,
St. Elizabeth Physicians, Edgewood, Kentucky
Summary: This study shares three-year outcomes data from
Castle’s prospective, multicenter study of patients with CM who
were being considered for an SLNB (n=322). SLNB is an invasive
surgical procedure used to determine whether a patient’s cancer has
spread to nearby lymph nodes; the procedure returns a surgical
result that is negative for metastasis in approximately 88% of
patients. Current National Comprehensive Cancer Network® guidelines
use a 5% likelihood of SLN positivity as the threshold to avoid
versus consider/recommend an SLNB due to an increased risk of
metastasis. DecisionDx-Melanoma has been validated to provide a
patient’s individualized risk of SLN positivity (i31-GEP for SLNB)
by integrating clinical and pathologic risk factors with the
patient’s tumor biology. In the study, no patients with a
DecisionDx-Melanoma predicted risk of SLN positivity less than 5%
had a positive SLN (among all tumor stages studied). If
DecisionDx-Melanoma was used to inform management decisions, the
test’s results could have further reduced the number of patients
with T1-T2 tumors who could have avoided SLNB by 25%. Additionally,
at three years, all patients with a low-risk DecisionDx-Melanoma
test result were recurrence free (recurrence free survival of
100%). These data demonstrate that use of DecisionDx-Melanoma test
results can guide accurate, risk-aligned clinical decision-making
regarding the SLNB surgical procedure, within current guidelines.
Further, the test can identify low-risk patients who can safely
consider foregoing SLNB, thereby reducing unnecessary SLNB
procedures (by approximately 25% in this study alone) and the
associated costs and risks of complications that accompany
them.
ePoster Number and Title: E309: Utility of 31-gene
expression profile test in identifying patients with T1 cutaneous
melanoma at high risk of SLN positivity and recurrence
Session: Melanoma Parallel Session
Summary: In a pooled cohort of 979 patients with thin
(T1) tumors, a DecisionDx-Melanoma Class 2B result was the
strongest predictor of a positive SLN, among other risk factors
that included patient age, tumor location, Breslow thickness, tumor
ulceration and more. While the study outlined above demonstrates
the ability of the test to identify patients at low risk of SLN
positivity who can safely forgo SLNB, this study shows that it can
also identify patients at high risk who should consider it. By
identifying patients who have a higher risk of SLNB positivity and
recurrence, DecisionDx-Melanoma can help determine which patients
should be considered for more intensive management, such as SLNB,
increased follow-up frequency and imaging surveillance, to improve
patient outcomes.
ePosters are available for conference attendees in the ePoster
Online Gallery.
About DecisionDx®-Melanoma
DecisionDx-Melanoma is a gene expression profile risk
stratification test. It is designed to inform two clinical
questions in the management of cutaneous melanoma: a patient’s
individual risk of sentinel lymph node (SLN) positivity and a
patient's personal risk of melanoma recurrence and/or metastasis.
By integrating tumor biology with clinical and pathologic factors
using a validated proprietary algorithm, DecisionDx-Melanoma is
designed to provide a comprehensive and clinically actionable
result to guide risk-aligned patient care. DecisionDx-Melanoma has
been shown to be associated with improved patient survival and has
been studied in more than 10,000 patient samples.
DecisionDx-Melanoma’s clinical value is supported by 50
peer-reviewed and published studies, providing confidence in
disease management plans that incorporate the test’s results.
Through Dec. 31, 2023, DecisionDx-Melanoma has been ordered more
than 150,000 times for patients diagnosed with cutaneous
melanoma.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle
Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the “safe harbor” created by those
sections. These forward-looking statements include, but are not
limited to, statements concerning: the ability of
DecisionDx-Melanoma test to (i) identify high risk patients who
could consider a more intensive treatment pathway, (ii) further
reduce the number of patients with T1-T2 tumors who could have
avoided SLNB by 25% and (iii) guide accurate, risk-aligned clinical
decision-making regarding the SLNB surgical procedure, within
current guidelines. The words “believe,” “can” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking
statements, and you should not place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that we make. These forward-looking
statements involve risks and uncertainties that could cause our
actual results to differ materially from those in the
forward-looking statements, including, without limitation:
subsequent study or trial results and findings may contradict
earlier study or trial results and findings or may not support the
results obtained in these studies, including with respect to the
discussion of our tests in this press release; actual application
of our tests may not provide the aforementioned benefits to
patients; and the risks set forth under the heading “Risk Factors”
in our Annual Report on Form 10-K for the year ended December 31,
2023, and in our other filings with the SEC. The forward-looking
statements are applicable only as of the date on which they are
made, and we do not assume any obligation to update any
forward-looking statements, except as may be required by law.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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